Hospital-based Home Care for Children With Cancer

NCT01538706 | Completed DMC

• 1 other identifier: 959584438
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this non-randomized controlled intervention study was to evaluate the effects of a hospital-based home care program for children with cancer at a university hospital in Denmark. The hypothesis was that hospital-based home care could replace an out-patient visit or an in-patient admission without increasing the incidence of adverse events and costs. Furthermore, to enhance the children's quality of life and the psychosocial impact on the family.

Conditions

Neoplasms; Children

Keywords

Hospital-based home care; Pediatric oncology

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  At each home visit, the hospital-based home care nurse recorded details on the HBHC visits and safety according to the mandatory hospital guidelines for registrations of adverse events such as acute deteriorations of the general condition, and any medical errors.

  17 months

Secondary Outcomes (5)

• Costs of the intervention

  17 months

• Healthrelated quality of life of the child with cancer

  At inclusion and 3 months after

• Psychosocial impact of the family with a child of cancer

  At inclusion and 3 months after

• Participants' satisfaction with health care

  At inclusion and 3 months after

• Participants' satisfaction with the hospital-based home care program

  12 months

Study Arms (1)

Hospital-based home care

EXPERIMENTAL

Patients were included if below the age of 18, had been diagnosed with any type of cancer at least one month prior to inclusion, on intravenous anticancer therapy with a curative intent, and the parent was fluent in speaking and reading Danish. Patients living within a radius of 50 kilometres from the hospital were assigned to the home care program. Moreover, patients were assigned to one of three groups according to the geographical distance from the hospital and timing of the inclusion period: (1) home care group if participating in the program, (2) historical standard care group for an eight-month period before the program started regardless of their residence distance from the hospital, and (3) concurrent standard care group if living more than 50 km from the university hospital.

Other: Hospital-based home care

Interventions

Hospital-based home care OTHER

Low-intensive intravenous antibiotics b) intravenous low-toxic chemotherapy c) blood samples drawn from the central venous catheter or peripheral vein d) subcutaneous injections e) nutrition treatment f) pain management (e.g. controlling an intravenous morphine pump g) supportive care e.g. changing dressings.

Hospital-based home care

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of cancer
• First-line treatment with intravenous therapy with a curative intent
• Have not received a haematopoietic stem cell transplantation
• Child and parent(s) speak and read Danish

You may not qualify if:

• End-of-life treatment
• Critical medical condition

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (1)

Copenhagen university hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Hansson H, Kjaergaard H, Schmiegelow K, Hallstrom I. Hospital-based home care for children with cancer: a qualitative exploration of family members' experiences in Denmark. Eur J Cancer Care (Engl). 2012 Jan;21(1):59-66. doi: 10.1111/j.1365-2354.2011.01280.x. Epub 2011 Aug 18.

  PMID: 21848580 RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Home Care Services, Hospital-Based

Intervention Hierarchy (Ancestors)

Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Helena Hansson, MSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinial Researcher and Nurse Specialist

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: February 24, 2012
• Study Start: August 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: October 1, 2010
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

DK (1)